Closure device

ABSTRACT

A closure device for closing an opening in tissue is provided. The closure device according the present invention includes a delivery system for deploying a closure element, wherein the closure element is movable between a delivery configuration and a deployed configuration to close an opening in tissue. The closure device of the present invention may further include a charge of hemostatic material.

CROSS REFERENCE

This application is a continuation of U.S. patent application Ser. No.12/608,773, filed Oct. 29, 2009 and entitled “CLOSURE DEVICE”, whichclaims the benefit of, and priority to, U.S. Provisional PatentApplication Ser. No. 61/109,822, filed on Oct. 30, 2008 and entitled“CLOSURE DEVICE,” and Ser. No. 61/143,748, filed on Jan. 9, 2009 andentitled “CLOSURE DEVICE,” all of which are incorporated in theirentireties herein by this reference.

BACKGROUND

1. The Field of the Invention

The present disclosure relates generally to systems, devices, andmethods for blocking an opening in body lumens. More particularly, thepresent disclosure relates to techniques for percutaneous closure ofarterial and venous puncture sites, which are usually accessed through atissue tract.

2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established duringthe well-known Seldinger technique. Vascular access is generallyprovided through an introducer sheath, which is positioned to extendfrom outside the patient body into the vascular lumen. When vascularaccess is no longer required, the introducer sheath is removed andbleeding at the puncture site stopped.

One common approach for providing hemostasis (the cessation of bleeding)is to apply external force near and upstream from the puncture site,typically by manual compression. This approach suffers from a number ofdisadvantages. For example, the manual compression procedure is timeconsuming, frequently requiring one-half hour or more of compressionbefore hemostasis is achieved. Additionally, such compression techniquesrely on clot formation, which can be delayed until anticoagulants usedin vascular therapy procedures (such as for heart attacks, stentdeployment, non-optical PTCA results, and the like) wear off. Theanticoagulants may take two to four hours to wear off, therebyincreasing the time required before completion of the manual compressionprocedure.

Further, the manual compression procedure is uncomfortable for thepatient and frequently requires analgesics to be tolerable. Moreover,the application of excessive pressure can at times totally occlude theunderlying blood vessel, resulting in ischemia and/or thrombosis.Following manual compression, the patient typically remains recumbentfrom four to as much as twelve hours or more under close observation toassure continued hemostasis. During this time, renewed bleeding mayoccur, resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusion and/or surgicalintervention.

The incidence of complications from the manual compression procedureincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. The compression technique forarterial closure can be risky, and is expensive and onerous to thepatient. Although the risk of complications can be reduced by usinghighly trained individuals, dedicating such personnel to this task isboth expensive and inefficient. Nonetheless, as the number and efficacyof translumenally performed diagnostic and interventional vascularprocedures increases, the number of patients requiring effectivehemostasis for a vascular puncture continues to increase.

To overcome the problems associated with manual compression, the use ofbioabsorbable sealing bodies is one example approach that has beenproposed. Generally, this example approach relies on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of problems. For example,bioabsorbable sealing bodies may lack a solid mechanical attachment ofthe sealing body to the tissue. Due to the lack of a solid mechanicalattachment, the sealing body can wander within the tissue tract or moveout of the puncture site, thus causing late bleeds. Conversely, if thesealing body wanders and intrudes too far into the arterial lumen, dueto the lack of a solid mechanical attachment, intravascular clots and/orcollagen pieces with thrombus attached can form and embolize downstream,causing vascular occlusion.

In addition to not having a solid mechanical attachment to the tissue,the sealing bodies may rely upon expandable materials to achievehemostasis. Again, the expandable materials lack the security of a hardmechanical closure, thus potentially causing late bleeds and prolonginghemostasis.

BRIEF SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. Embodiments of the present invention provide systems, methods,and devices for closing an opening in tissue. Embodiments of theinvention can be configured to close an opening within a body lumen.

In one example embodiment, a device for closing an opening in tissueincludes a tubular body member having a wall thickness, a proximal end,and a distal end. The tubular body member of the device may includeslits formed within the tubular member through the wall thickness. Theslits are arranged above and below a waist portion located between theproximal end and distal end of the tubular body member.

In another example embodiment, a device for closing an opening in a bodylumen wall includes a tubular body element having a first portion, asecond portion, and a waist portion located between the first portionand second portion. The first and second portions have a deliveryconfiguration and a deployed configuration. When the first and secondportions are in the delivery configuration they have a deliverycross-sectional dimension, and when the first and second portions are ina deployed configuration they have a deployed cross-sectional dimension.The deployed cross-sectional dimension is larger than the deliverycross-sectional dimension.

Another example embodiment discloses a system for closing an opening ina body lumen. The system includes a closure element having a deliveryconfiguration and a deployed configuration. The system further includesan actuator that is coupled to the closure element and operativelyassociated with a handle assembly. The handle assembly includes arotatable handle element that may be inserted into a hub member suchthat when the handle element is rotated, the closure element changesfrom the delivery configuration to the deployed configuration.

In another example embodiment, a method for closing an opening in a bodylumen is disclosed. The method includes inserting a closure device intoan opening in a body lumen wall, the closure device including a closureelement and actuator. After inserting the closure device, a force isapplied to the closure element by way of the actuator such that a firstportion of the closure element changes from a delivery configuration toa deployed configuration. Next, a second force may be applied to theclosure element by way of the actuator such that a second portion of theclosure element changes from a delivery configuration to a deployedconfiguration.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a cross-sectional view of the closure device in accordancewith one embodiment of the present invention;

FIG. 2A is a close-up cross-sectional view of an example embodiment of aclosure device in accordance with the present invention;

FIG. 2B is a close-up cross-sectional view of an example embodiment of aclosure device in accordance with the present invention and furtherillustrating a locking mechanism formed therewith;

FIG. 2C is a cross-section view of an example embodiment of a closureelement in a deployed configuration;

FIGS. 3 through 6 illustrate the use of an example closure device inaccordance with the present invention;

FIGS. 7A through 9B illustrate various embodiments of a closure elementin accordance with the present invention;

FIGS. 10 and 11 are cross-sectional views of an alternative embodimentof a closure device including a charge of a hemostatic material;

FIG. 12 is a flow chart showing an example method of closing an openingin tissue in accordance with the present invention;

FIG. 13A is an exploded illustration of a delivery system of oneembodiment of the present invention;

FIG. 13B is a top view of a portion of the delivery system of FIG. 13Aaccording to one embodiment of the present invention;

FIG. 13C is another illustration of the delivery system of FIG. 13Aaccording to one embodiment of the present invention;

FIG. 13D is a cross-section illustration of a portion of the deliverysystem of FIG. 13A;

FIG. 13E is a further illustration of the delivery system of FIG. 13A;

FIG. 13F is a yet further illustration of the delivery system of FIG.13A; and

FIG. 13G is a perspective illustration of the delivery system of FIG.13A in combination with an introducer sheath according to anotherembodiment of the present invention.

DETAILED DESCRIPTION

In accordance with the present invention there is provided a closuredevice configured to close an opening formed in tissue. The closuredevices described herein may be formed of a bioabsorbable material ormay be formed of a biocompatible material. It is further contemplatedthe closure device may be coated with a covering membrane and/or anotherbiocompatible coating as will be described in greater detail below. Inone embodiment, the closure device may be configured to be receivedwithin the lumen of a medical sheath, for example, in accessing thepatient's femoral artery, the physician will typically utilize a 6French sheath. The closure device may be configured to be receivedwithin the lumen of this 6 French sheath. However, it can be understoodthat embodiments of the closure device may be configured to be receivedwithin multiple sizes of sheaths and should not be limited to theexample above.

FIG. 1 illustrates one example embodiment of a closure device 10. Asshown in FIG. 1 the closure device 10 may include an elongate member 12that has a proximal end 14 and a distal end 16. The elongate member 12may also include a passage 18 that extends from the proximal end 14towards the distal end 16. Within the passage 18 of the elongate member12, a protrusion 20 extends into the passage 18, thus reducing thecross-sectional dimension of the passage 18 at a location that isbetween the proximal end 14 and the distal end 16 of the elongate member12. The closure device 10 further includes an actuator 22 that extendsthrough the passage 18 of the elongate member 12. A closure element 100extends beyond the elongate member 12 and may be coupled to the actuator22.

In operation, the closure device 10 may be inserted into a body lumen 30as illustrated in FIG. 1. In one embodiment, the elongate member 12 andthe closure element 100 pass through the proximal luminal wall 34 of thebody lumen 30. While within the body lumen 30 the closure element 100 ischanged from a delivery configuration, as illustrated in FIG. 1, to adeployed configuration as illustrated in FIG. 2C. While in the deployedconfiguration the closure element 100 is able to block or otherwiseclose a puncture in the proximal luminal wall 34.

Referring back to FIG. 1, the structure of the closure device 10 will bediscussed in more detail. In particular, the closure device 10 may haveconfigurations and characteristics that vary from one embodiment to thenext. For example, the elongate member 12 is one aspect of the closuredevice 10 that may vary from one embodiment to the next. In particular,the elongate member 12 may have various geometric configurations. Asillustrated in FIG. 1, the elongate member 12 may have a substantiallycircular cross-sectional geometric configuration. In other embodiments,however, the cross-sectional configuration of the elongate member 12 mayvary and take various other configurations such as oval, square,triangular or any other configuration or combination of configurations.

Along with the various cross-sectional configurations of the elongatemember 12, the passage 18 may also have various cross-sectionalconfigurations. The cross-sectional configuration of the elongate member12 may or may not match the cross-sectional configuration of the passage18. Moreover, the cross-sectional configurations of the elongate member12 and the passage 18 may vary from the proximal end to the distal endof the elongate member 12.

Notwithstanding variations in the geometric configuration, the elongatemember 12 may be configured to retain the closure element 100 at thedistal end 16 of the elongate member 12. In one example embodiment,illustrated in FIG. 1, the elongate member 12 further includes aprotrusion 20 that protrudes inwardly into the passage 18 such that theclosure element 100 is not permitted to pass the protrusion 20. Theprotrusion 20, as illustrated in FIG. 1, also may include a passage suchthat the actuator 22 may pass through the protrusion section 20 andcontact or couple to the closure element 100.

In one example, and as illustrated in FIG. 1, the closure element 100 isgenerally allowed to be inserted only about halfway into the passage 18of the elongate member 12 and thereafter is blocked from being insertedfurther into the elongate member 12 by the protrusion 20. The locationof the protrusion 20 may vary from one embodiment to the next. In otherexample embodiments, the protrusion 20 may be positioned more proximallywithin the passage 18 of the elongate member 12, or alternatively, theprotrusion 20 may be positioned more distally within the elongate member12. Thus, the position of the protrusion 20 may allow the closureelement 100 to either be further inserted into the elongate member orhave more of the closure element 100 positioned outside the elongatemember 12.

In addition to variations of the protrusion 20 within the passage 18 ofthe elongate member 12, the distal end 16 of the elongate member 12 mayalso vary. For example and as illustrated in FIG. 1, the distal end 16of the elongate member 12 may have a radius. This radius, for instance,may assist when inserting the elongate member 12 into a tissue tract andsubsequently into the body lumen 30 through the proximal luminal wall34. In other example embodiments, the distal end 16 of the elongatemember 12 may have various other configurations. For example, they mayhave various ranges of radii as well as various other geometricconfigurations, for example, square, triangular, or rectangular.

In addition to the geometric configuration variations, the elongatemember 12 may also have various material characteristics. For example,in one embodiment the elongate member 12 may be formed of a rigidmaterial such as a stainless steel or other biocompatible material thatis rigid. Alternatively, the elongate member 12 may be formed of aflexible material such as those materials utilized to form cathetershafts, introducer sheaths, or other medical devices. Suitable materialsinclude polyvinyl chloride (PVC), peak, PTFE, nylon, or any othersimilar materials.

As discussed, the actuator 22 may extend through the elongate member 12.The actuator 22 is another aspect of the closure device 10 that may varyfrom one embodiment to the next. As shown in FIG. 1, the actuator 22extends through the passage 18 of the elongate member 12 and couples toor attaches to the closure element 100. One way in which the actuator 22may vary is the cross-sectional geometric configuration of the actuator.FIG. 1 illustrates an actuator 22 that has a substantially circularcross-sectional configuration. In other example embodiments, thecross-sectional geometric configuration of the actuator 22 may vary andinclude configurations such as square, triangular, rectangular or anyother geometric configuration. In one example embodiment, the geometricconfiguration of the actuator 22 may be configured to match thecross-sectional geometric configuration of the passage 18 within theelongate member 12.

Another way in which the actuator 22 may vary is the material from whichthe actuator 22 is made. For example, the actuator 22 may be made from arigid material such as stainless steel or other biocompatible materialsthat are rigid. Alternatively, the actuator 22 may be formed of aflexible material, for example, if the elongate member 12 is made from aflexible material. Examples of flexible actuator 22 materials includepolyvinyl chloride (PVC), peak, PTFE, nylon, or similar materials.Generally, the actuator 22 material may be made from any material thatis able to have enough strength and structural properties to change theclosure element 100 from a delivery configuration, as shown in FIG. 2A,to a deployed configuration, as shown in FIG. 2C.

Another way in which the actuator 22 may vary is the way in which itconnects to or attaches to the closure element 100. FIG. 2B illustratesa cross-sectional view of the closure element 100 that shows one exampleof connecting the actuator 22 to the closure element 100. For example,actuator 22 may include a coupler element 24 that is configured tocouple to the distal end 106 of the closure element 100. In one exampleembodiment, and as illustrated in FIG. 2B, the coupler element 24includes a section that has a larger cross-sectional dimension than theactuator 22. In this example, the coupler element 24 may interface withthe distal end 106 of the closure element 100 such that the couplerelement 24 is held by the material of the closure element 100 (e.g., theclosure element 100 material surrounds the coupler element 24. In otherexample embodiments, the coupler element may simply attach to or coupleto the distal end 106 of the closure element 100 by an adhesive or otherbonding means.

In addition to the coupler element 24, the actuator 22 may also includea locking element 26, as illustrated in FIG. 2B. The locking element 26may vary from one embodiment to the next. For example, and asillustrated in FIG. 2B, the locking element 26 has a triangularconfiguration, however, in other example embodiments the geometricconfiguration of the locking element may take various forms such assquare, rectangular, oval, circular or any other configuration.

In particular, the geometric configuration of the locking element 26 isconfigured such that the locking element 26 and the proximal end 104 ofthe closure element 100 cooperate to lock the closure element 100 in thedeployed configuration. For example, and as illustrated in FIGS. 2B and2C, the locking element 26 may be pulled through the proximal end 104 ofthe closure element 100. Once pulled through the proximal end 104 of theclosure element 100, the locking element 26 and/or the proximal end 104of the closure element 100 may be configured such that the lockingelement 26, in combination with the proximal end 104 of the closureelement 100, restricts the actuator from moving distally with respect tothe closure element 100. In other words the locking element 26 may beconfigured to facilitate removal of the locking element 26 from withinthe closure element 100, but after removal from the closure element 100,the locking element 26 may not be allowed to re-enter the closureelement 100.

Notwithstanding the various configurations and characteristics of boththe elongate member 12 and the actuator 22, the closure element 100 maybe configured to be operatively associated with the elongate member 12and the actuator 22 in order to be delivered and deployed in an openingwithin a body lumen. Continuing now with FIGS. 2A, 2B, and 2C, theclosure element 100 will be discussed in more detail. As illustrated inFIG. 2A, the closure element 100 may include a body member 102 that hasa proximal end 104 and a distal end 106. The body member 102 may alsoinclude a waist portion 108 that separates a plurality of proximal slits110 from a plurality of distal slits 112. Moreover, the closure element100 may have a delivery configuration, as illustrated in FIG. 2A, and adeployed configuration, as illustrated in FIG. 2C.

As with other aspects of the closure device 10, the closure element 100may vary from one embodiment to the next. One way in which the closureelement 100 may vary is the cross-sectional configuration of the closureelement 100 body member 102. For example, and as illustrated in FIG. 2A,the body member 102 may have a generally cylindrical cross-sectionalconfiguration. In other example embodiments, the cross-sectionalconfiguration of the body member 102 may take various forms such assquare, rectangular, triangular or any other cross-sectionalconfiguration.

Another way in which the closure element 100 may vary is the geometricdimensions of the proximal slits 110 and/or distal slits 112. Forexample, the geometric configuration of the upper and lower slits 110and 112, as shown in FIG. 2A, may be a generally rectangularconfiguration. However, in other example embodiments the geometricconfiguration of the proximal slits 110 and/or the distal slits 112 maytake various other geometric configurations such as more square,triangular, oval or any other configuration or combinationconfigurations. The slits may be formed within the wall of the bodymember 102 using known manufacturing techniques such as cutting, lasercutting, water jet cutting. Alternatively, the slits may be integrallyformed within the body member 102 during manufacturing such as throughthe use of injection molding.

Furthermore, and as illustrated in the example embodiment in FIG. 2A,the proximal slits 110 may have substantially the same configuration anddimensions as the distal slits 112. In other example embodiments,however, the proximal slits may have a different geometric configurationand/or dimension compared to the distal slits 112. For example, in oneembodiment, the proximal slits 110 may have a different length and widthas the distal slits 112, or the proximal slits 110 may have a differentgeometric configuration relative to the distal slits 112.

In addition to variations between the proximal slits 110 and the distalslits 112, the geometric configuration and the dimensions of theproximal slits 110 and/or distal slits 112 may vary from one slit to thenext. For instance, the upper slits 110 may have a variety of differentsized and configured slits that make up the plurality of upper slits110. Similarly, the lower slits 112 may be made up of a variety ofdifferent sized and configured individual slits.

Another way in which the proximal slits 110 and distal slits 112 mayvary is the alignment configuration between the proximal slits 110 withrespect to the distal slits 112. For example, as illustrated in FIG. 2A,the proximal slits 110 may be substantially aligned with the distalslits 112. However, in other example embodiments, the proximal slits 110may be positioned such that the proximal slits are misaligned with thedistal slits 112. In the same respect, the number of proximal slits 110compared to the number of distal slits 112 may vary from one embodimentto the next. As shown in FIG. 2A, there are an equal number of proximalslits 110 relative to the number of distal slits 112. In other examples,however, the closure element 100 may have more proximal slits 110compared to distal slits 112. For example, a closure element may beconfigured such that there are six distal slits equally spaced aroundthe body member 102 of the closure element 100, while there are onlyfour proximal slits 110 positioned and equally spaced around the bodymember 102 of the closure element 100.

As can be understood, the spacing between each individual slit may alsovary from one embodiment to the next, as well as from one slit to thenext. For example, and as previously mentioned, the upper and/or lowerslits 110 and 112 may have the slits positioned and equally spacedaround the body member 102. Alternatively, the slits may be positionedaround the body member 102 such that the spacing between slits varies.

The distance between the proximal slits 110 and the distal slits 112 isanother aspect of the closure element 100 that may vary from oneembodiment to the next. In one example embodiment, the distance betweenthe proximal slits 110 and the distal slits 112 is a distance that wouldbe approximately equal to the width of a body lumen wall. For example,the distance between the upper and distal slits may be equal to thewidth of the proximal lumen wall 34, illustrated in FIG. 1. In thismanner, the closure element 100, when in the deployed configuration,would assist in blocking an opening within the proximal lumen wall 34.

FIG. 2B illustrates various other aspects of the closure element 100that may vary from one embodiment to the next. For example, FIG. 2Billustrates that the closure element 100 may include an aperture 105located on the proximal end 104 of the body member 102. In oneembodiment, the proximal end 104 of the body member 102 of the closureelement 100 may be made of material that is flexible such that thelocking element 26 of the actuator may be pulled in a proximal directionthrough the aperture 105 located on the proximal end 104 of the closureelement 100. Moreover, the proximal end 104 of the body member 102 mayhave a geometric and/or material configuration that allows the lockingelement 26 or similar feature of the actuator to pass through in onedirection (i.e. the proximal direction) but not pass through in theopposite direction (i.e. the distal direction).

For example, the proximal end 104 may be configured with a plurality ofcuts that are arranged in a generally circular pattern around theaperture 105 such that each cut extends away from the aperture along aradius line. The cuts may be formed at an angle such that the materialon the proximal end 104 between the cuts are allowed to flex in adirection that would allow the locking element 26 to pass through theaperture 105 of the closure element 100. However, once the lockingelement 26 has passed through the aperture 105, the proximal end 104material between the cuts is not permitted to flex to allow the lockingelement 26 to again pass through the aperture 105. In other words, thematerial at the proximal end 104 of the closure element 100 may onlyflex in one direction and thus resist movement of the locking element 26in the distal direction after the locking element 26 has passed throughthe aperture 105.

The locking element 26, along with the configuration of the closureelement 100 assist to change the closure element 100 from a deliveryconfiguration, shown in FIGS. 1 and 2A, to a deployed configurationshown in FIG. 2C. In one embodiment, the actuator 22 cooperates with theclosure element 100 to collapse the body member 102 of the closureelement such that the proximal slits 110 and the distal slits 112 allowthe portions of the body member 102 between the proximal slits 110 anddistal slits 112 to collapse and flex radially outwardly. Moreover, whenin the deployed configuration, the actuator 22, with the locking element26 and the coupler element 24 may cooperate with the closure element 100such that the body member 102 of the closure element 100 may be changedinto, and held locked in, the deployed configuration. Specifically, thelocking element 26 cooperates with the coupler element 24 such that thebody member 102 of the closure element 100 is held in place in thedeployed configuration between the locking element 26 and the couplerelement 24.

The deployed configuration of the closure element 100 may have variousconfigurations. For example, in one embodiment, the deployedconfiguration of the closure element 100 may provide a clamping forceupon the body lumen wall, thus holding the closure element 100 in placewithin the opening in the body lumen. Additional characteristics andconfigurations of the closure element 100 in the deployed configurationwill be discussed with respect to FIGS. 6 through 9B.

Another way in which the closure element 100 may vary is the type ofmaterial used to make the closure element 100. In one embodiment theclosure element 100 is manufactured from a bioabsorbable, bioresorbable,bioerodible, and/or biodegradable material. Examples of suitablematerials for use are metals, metal alloys, polymers or combinationsthereof that decompose or biodegrade in a biological environment such aswithin a body lumen. For example, and not by limitation, suitablebioabsorbable materials may include magnesium, zinc, silicon, lithium,zinc titanium, magnesium lithium, polyglocic acid (PGA),polyhydroxybutyric acid, polyL-Lactic acid (PLLA), polydilactidelglycolide acid, polydilactid acid, PolyDL Lactide-co-gycolide,Polylactic acid, Polylicolic acid, Polyhydroxyalkanoates or derivativesthereof and any combination thereof.

In addition to the various types of materials that may be used tomanufacture the closure element 100, the closure element 100 may includeadditional material properties that may be useful. For example, theclosure element 100 may be covered with a flexible membrane to aid insealing the opening. The flexible membrane may be formed of a flexiblebio-compatible or bioabsorbable material such as any of those that weredescribed above. Moreover, the closure element 100 may further include abeneficial agent either disposed thereon as a coating or integrallyformed within the absorbable material wherein the beneficial agent wouldbe configured to aid in healing and/or reduce the potential forinfection.

Moreover, material properties may be included in the closure element 100to help a user place the closure element 100. For example, the closurecomponent 100 may further include a radiopaque marker or radiopaquecoating in order to aid the user in positioning the closure element 100within the puncture site of the body lumen. The radiopaque marker may beformed within the wall of the body member 102 in the form of a rivet.Alternatively, a radiopaque coating may be disposed on the body member102 as a thin coating of radiopaque metal such as gold, tantalum,alydium, platinum, uridium or similar metals.

Referring now to FIGS. 3 through 6, the operation of the closure device10 will be explained in more detail. Initially, the closure device 10 isinserted in a tissue tract and disposed through an opening or puncturewithin a body lumen. For example and as shown in FIG. 1, the closuredevice 10 may be disposed through the proximal lumen wall 34 of the bodylumen 30. After disposing the closure device 10 through the opening inthe proximal lumen wall 34 the closure element 100 may be changed from adelivery configuration to a deployed configuration.

In one embodiment, the process of changing the closure element 10 from adelivery configuration to a deployed configuration begins withpositioning the closure element 100 within the elongate member 12 suchthat the distal slits 112 are located outside of the elongate member 12and the proximal slits 110 are located within the elongate member 12. Inone example, this position of the closure element 100 may correspond tothe protrusion 20 located within the elongate member 12 as discussedabove and as illustrated in FIG. 3.

With the distal slits 112 positioned outside of the elongate member 12,the actuator 22 may be moved in the proximal direction (as indicated bythe arrow in FIG. 3) such that the portions of the body member 102located in-between the distal slits 112 are forced to collapse, bend,and/or buckle and extend in an outward direction as shown in FIG. 3. Inparticular, the actuator 22 may pull the distal end 106 of the closureelement 100 in a proximal direction by way of the coupler element 24that is coupled to the distal end 106 of the closure element 100. Thedistal slits 112 may weaken the body member 102 such that uponexperiencing the force associated with pulling the distal end 106 of theclosure element 100 in the proximal direction, the portions of the bodymember 102 in-between the distal slits 112 collapse, the collapsingportions of the body member 102 extending out from the closure element100. On the other hand, because the proximal slits 110 are positionedwithin and stabilized by the elongate member 12, the portions of thebody member 102 in-between the proximal slits 110 may not collapse.

Once the portions of the body member 102 in-between the distal slits 112have collapsed, the closure device 10 may be moved in the proximaldirection such that the deployed lower section of the closure element100 is generally in contact with the inside portion of the proximallumen wall 34, as illustrated in FIG. 4. At this position, the deployedsection of the closure element 100 is within the body lumen 30, thewaist portion 108 of the closure element 100 extends through the openingin the proximal lumen wall 34, and the proximal slits 110 are locatedoutside the body lumen 30.

When in this position, the elongate member 12 may be moved in a proximaldirection relative to the closure element 100 such as to reveal orrelease the proximal slits 110 from the elongate member 12. In oneexample embodiment, the actuator 22 is held in substantially a constantposition, while the elongate member 12 is pulled or otherwise moved in aproximal direction with respect to the closure element 100. Moreover,the distal end 16 of the elongate member 12 may be configured with abias that applies a radially compressive force on the closure element100. Thus, once the closure element is released from the elongate member12, the user may sense the release and/or feel that the resistance tothe movement of the elongate member 12 has changed indicating that theproximal slits 110 have been released from the elongate member 12.

At this point the proximal slits 110 are now in position for theproximal portion of the closure element 100 to be deployed. Asillustrated in FIG. 5, the proximal portion of the closure element 100is deployed by having the portions of the body member 102 in-between theproximal slits 110 collapse such that the portions of the body member102 in-between the proximal slits 110 extend radially outwardly asillustrated in FIG. 5. In order to deploy the upper portion of theclosure element 100, the actuator 22 may be moved in a proximaldirection (as illustrated by the arrow in FIG. 5) thus applying a forceto the closure element 100 that causes the portions of the body member102 in-between the proximal slits 110 to collapse and extend outwardly.

Moreover, and as illustrated in FIG. 5, during or after the deploymentof the proximal portion of the closure element 100, the locking element26 located on the actuator 22 may be pulled through the aperture 105 inthe proximal end 104 of the closure element 100. The locking element 26is then allowed to rest or push on the proximal end 104 of the closureelement 100 such that the closure element is held in the deployedconfiguration between the locking element 26 and the coupler element 24of the actuator.

FIG. 6 shows a close-up view of a deployed closure element 100 within anopening of a body lumen 30. As shown in FIG. 6, the proximal slits 110and distal slits 112 have allowed the proximal and distal portions ofthe body member 102 to collapse, and thus the portions of the bodymember 102 in-between the slits have extended outwardly such that theproximal lumen wall 34 is located between the collapsed proximal portionand the collapsed distal portion of the closure element 100. The waistportion 108 of the body member 102 may be located at least partiallywithin the opening in the proximal lumen wall 34 of the body lumen 30.

FIG. 6 further illustrates that the deployed closure element 100 may beheld in a deployed configuration by the coupler element 24 and thelocking element 26. In particular, the locking element 26 cooperateswith the coupler element 24 such that the closure element 100 issqueezed or otherwise restricted between the coupler element 24 and thelocking element 26. In this way, the portions of the body member 102that have collapsed are held in the collapsed or deployed configurationand are not permitted to return to the pre-collapsed or deliveryconfiguration.

Once the closure element 100 is locked in the deployed configuration,the actuator 22 portion proximal to the locking element 26 may besevered or cut using a secondary cutting device or, alternatively, theactuator 22 may be configured such that upon application of anotherproximal force a weakened portion of the actuator 22 allows the actuatorto break free at a location on the actuator 22 that is proximal to thelocking element 26. The severed actuator 22 and the elongate member 12are then removed from the tissue tract leaving the deployed closureelement 100 within the puncture or opening within the body lumen 30.

FIGS. 7A through 8B illustrate various additional example embodiments ofthe closure element 100. For example, FIG. 7A illustrates a closureelement 100 that includes a body member 102 with a proximal end 104 anda distal end 106. The body member 102 has proximal slits 110 and distalslits 112 formed within the body member 102 of the closure element 100.The proximal slits 110 and the distal slits 112 may have variousarrangements and alignments with respect to one another. The arrangementand alignment of the proximal slits 110 and the distal slits 112 mayaffect the deployed configuration of the closure element 100. Thus, theproximal slits 110 and the distal slits 112 may have almost anyarrangement and alignment configurations that subsequently determine thedeployed configuration of the closure element 100.

For example, and as illustrated in FIGS. 7A through 7B, the closureelement 100 may take various forms. In particular, the example closureelement 100, illustrated in FIG. 7A, includes proximal slits 110 thatare offset from the distal slits 112. In other words, the proximal slits110 are not vertically aligned with the distal slits 112. This exampleoffset arrangement of the proximal and distal slits 110 and 112 mayresult in the closure element 100 having a deployed configuration asillustrated in FIG. 7B.

Specifically, when in the deployed configuration, the closure element100 has upper extensions 114 and lower extensions 116. As illustrated inFIG. 7B, the upper extensions 114 may be offset from the lowerextensions 116 such that the upper extensions 114 and lower extensions116 alternate as viewed from the distal end 106 of the closure element100. In other example embodiments, the upper extensions 114 and lowerextensions 116 may be configured such to have any pattern of alignmentor arrangement with respect to one another or with respect to otherportions of the closure element 100 depending on the alignment orarrangement of the proximal slits 110 with respect to the distal slits112.

FIG. 8A shows another alternative embodiment of the closure element 100that varies the configuration of the proximal slits 110 and the lowerslits 112 to produce another example of the deployed configuration ofthe closure element 100. As illustrated in FIG. 8A, the closure element100 has a body member 102 that has a proximal end 104 and distal end 106and also includes a waist portion 108. The waist portion 108 ispositioned between proximal slits 110 and distal slits 112. In thisexample embodiment, the proximal and distal slits 110 and 112 are curvedor have a radius, as illustrated in FIG. 8A. The curved proximal slits110 and curved distal slits 112 produce curved upper and lowerextensions 114 and 116 when the closure element 100 is changed into thedeployed configuration. Moreover, and as illustrated in FIG. 8B, thecurved upper and lower extensions 114 and 116 may alternate one fromanother. As with the embodiment shown in FIG. 7A, the curved upper andlower extensions 114 and 116 may have any alignment or arrangementconfiguration with respect to one another.

In addition to the two embodiments of the closure element 100,illustrated in FIG. 7A through FIG. 8B, the upper and distal slits 110and 112 may have various other configurations such as a zigzag pattern,an oval pattern or any other pattern or configuration that would producevarious arrangement and alignment configurations of the upper extensions114 and/or lower extensions 116. Moreover, there can be any combinationbetween the proximal slits 110 and the distal slits 112. For example,the proximal slits may take on a more rectangular configuration, asshown in FIG. 7A, and the distal slits 112 may take on a curvedconfiguration as shown in 8A. Thus, the deployed configuration of theclosure element 100 may have upper extensions 114 that are rectangular,as shown in 7B, and lower extensions 116 that are curved, as shown inFIG. 8B.

Although FIGS. 7A through 8B addresses various example configurations ofthe closure element 100 that have proximal and distal slits 110 and 112,the closure element 100 may be configured to not contain any slits. Forexample, FIGS. 9A and 9B show an example embodiment of a closure element100 that does not include any proximal or distal slits; however, theclosure element 100 is still able to collapse such to form the deployedconfiguration of the closure element 100. In particular, the sidewall ofthe closure element 100, as illustrated in FIG. 9B, may includeindentations 118 or other areas within the wall that create naturalweaknesses or breaking points. The indentations 118 within the closureelement wall 120 may be configured such that when a compressive force isapplied from the actuator 22, the closure element 100 collapses aroundthe weakened portions of the indentation 118.

The indentations 118, shown in FIG. 9B, may vary from one embodiment tothe next. For example, the number of indentations that are located onthe sidewall 120 of the closure element 100 may vary. In one exampleembodiment illustrated in FIG. 9B, the sidewall 120 of the closureelement 100 includes two indentations 118. Each indentation 118 wouldproduce extensions when the closure device is changed to the deployedconfiguration, thus two extensions (for example an upper and lowerextension) would be made from the example embodiment shown in FIG. 9B.However, in other example embodiments, more or less indentations may beused in order to create various or multiple sections of that collapse toform a barrier within an opening of a body lumen.

FIGS. 10 and 11 show another optional embodiment of a closure device200. As illustrated in FIG. 10, closure device 200 may include anelongate member 12 that has a passage 18 extending through from aproximal end to a distal end. The elongate member 12 may be configuredto accept and retain a closure element 100. The closure element mayinclude a proximal end 104, a distal end 106, and a waist portion 108that is located between the proximal end 104 and the distal end 106. Inone embodiment, the closure element 100 may contain proximal slits 110and distal slits 112, as previously discussed. Closure device 200further includes an actuator 22 that is connected to the closure element100. The actuator 22 is associated with a second actuator 40. Locatedwithin the passage 18 within the elongate member 12 may be a hemostaticagent 50.

In one example embodiment of the closure device 200, the second actuator40 has a slightly larger cross-sectional dimension than thecross-sectional dimension of the actuator 22. In this way a space islocated in the passage 18 between the elongate member 12 and theactuator 22 such that a hemostatic agent 50 may be placed next to theactuator 22. Moreover, the second actuator 40 may be configured andsized appropriately such that the clearance between the second actuator40 and the elongate member 12 through the passage 18 is minimal,allowing the second actuator 40 to press or move the hemostatic agent 50through the passage 18 of the elongate member 12.

As shown in FIG. 11, the basic operation of the closure device 200 maybe similar to the basic operation previously discussed with closuredevice 10. However, in this embodiment after the closure element 100 issecured in the deployed configuration about the proximal lumen wall 34,the second actuator 40 will then be positioned to press the hemostaticagent 50 out of the elongate member 12. Specifically, once the closureelement 100 is in the deployed configuration, the elongate member 12 maybe moved in the proximal direction and the second actuator 40 may bepressed in the distal direction such that the hemostatic agent 50 isforced out of the elongate member 12 and onto the surface of thedeployed closure element 100, and thus the hemostatic agent may bedeposited onto the portion of the proximal lumen wall 34 that is in thegeneral area of the deployed closure element 100.

The hemostatic agent 50 may be any material configured to aid in thehealing of the body lumen wall as well as to cause the cessation ofbleeding. Moreover, the hemostatic agent 50 may contain any material oragent that may be used to avoid infection. Suitable hemostatic materialsfor any of the embodiments described above may include chitosan,collagen, thrombin, PEG or other biocompatible materials. In oneembodiment, chitosan may be utilized. The chitosan hemostaticcomposition may provide a strong clotting action to seal a hole,puncture, incision, or any other bleeding site to promote enhancedhealing of the bleeding site and reduce opportunities for infection.Additionally, the chitosan hemostatic composition can be configured toswell in the presence of blood to form a hemostatic barrier that coversor otherwise plugs the bleeding site.

Chitosan is a polycationic polymer derived from chitin, which can alsobe used as described herein. Chitosan has a positive charge from primaryamine groups that can interact with the negative charge of the lipidspresent on cell surfaces, such as blood cells. This electrostaticinteraction has been identified as an aspect of the hemostaticproperties of chitosan. Dry chitosan compositions can have increasedhemostatic properties by increasing surface area, and thereby thecontact area with blood. Processing methods, such as freeze drying,puffing, foaming, sponging, ballooning, combinations thereof, or thelike, can be used to provide a porous, open cellular, or closed cellularstructure with increased surface area. In addition to chitosan and/orchitin, other polymers having N-acetylglucosamines and N-glucosamines,such as poly-beta-1→4-N-acetylglucosamines with or without one or moremonosaccharides being deacetylated and poly-beta-1→4-N-glucosamines, andderivatives thereof.

The chitosan or other similar polymer used in various embodiments of thepresent invention may be purified to facilitate use in a medical deviceand or used within the body of a subject. This may include beingpurified to remove proteins, other organic or inorganic contaminants.Such purification and processing of chitosan is well known in the art.Accordingly, the chitosan or other similar polymer can be considered tobe biocompatible, immunoneutral, and/or generally recognized as safe foruse with or within a subject, such as a human or other animal.

Once the hemostatic agent 50 has been deployed next to the deployedclosure element 100, the elongate member 12 along with the associatedactuator 22 and second actuator 40 may be removed from the patient.

The closure device discussed with the various example embodiments of thepresent invention may include various other configurations. For example,any configuration of the closure device that includes a closure elementthat is able to anchor on the inside surface of the body lumen wall aswell as on the outside surface of the body lumen wall (i.e. sandwich thewall of the body lumen between two closure elements or two closureelement portions) may be used with the closure device contemplated withthe present invention.

Accordingly, the previous figures and the corresponding text provide anumber of different components and systems that may be used to close anopening in a body lumen. In addition to the foregoing, other exampleembodiments may also be described in terms of flowcharts comprising oneor more acts in a method for accomplishing a particular result. Forexample, FIG. 12 illustrates a method 600 of closing an opening intissue. The acts of method 600 are discussed more fully below withrespect to the disclosures of FIGS. 1 through 11.

For example, FIG. 12 shows that a method in accordance with an exampleimplementation of the invention may include inserting 602 a closuredevice into an opening in a body lumen wall. Inserting a closure devicemay involve inserting a closure device into an opening formed in tissue,the closure device including a delivery tube, an actuator, and a closureelement, the closure element defined by a body having a proximalportion, a distal portion and a waist. For example, as shown in FIG. 3,the closure element 100 may be inserted through the proximal lumen wall34.

After the closure device is inserted into an opening, a force may beapplied 604 to the actuator to move a first portion of a closure elementfrom a first configuration to a second configuration. Applying a forcemay involve applying a force to the actuator to move the distal portionof the closure element from a first configuration toward a secondconfiguration, wherein in the second configuration, portions of theclosure element protrude from the body. For example, as shown in FIG. 3,the actuator 22 may be moved in a proximal direction (as indicated bythe arrow) such that the portions of the body member 102 locatedin-between the distal slits 112 are forced to collapse, bend, and/orbuckle and extend in an outward direction thus causing the distalportion of the closure element 100 to change from a deliveryconfiguration to a deployed configuration.

Next, a second force may be applied 606 to an actuator to move a secondportion of the closure element from a first configuration towards asecond configuration. Applying a second force may involve applying asecond force to the actuator to move the proximal portion of the closureelement from a first configuration toward a second configuration. Forexample, and as illustrated in FIG. 5, the actuator 22 may be moved in aproximal direction, thus causing the portions of the body member 102in-between the proximal slits 110 to collapse and extend outwardly.

FIGS. 13A through 13G illustrate an example embodiment of a closuredevice that uses a handle assembly 400. In particular, FIG. 13Aillustrates a closure device that includes a handle assembly 400 thathas a handle element 402 and a hub member 404. The handle element 402has a proximal end 406, a distal end 408, a grip portion 410, and anextended portion 412. Projections 414 may extend from the extendedportion 412. Moreover, the handle element 402 includes a port 416through which an actuator 22 may extend.

The handle element 402 is operatively associated with a hub member 404.The hub member 404 includes a hub body 418 that has a proximal end 420and a distal end 422. A channel 424 is formed within the hub body 418 ofthe hub member 404, the channel 424 configured to cooperate with theprojections 414 located on the handle element 402. An elongate member 12may be connected to the hub member 404. The elongate member 12 may beconfigured such that an actuator 22 may extend through the elongatemember 12. Attached to a distal end of the actuator 22 is a closureelement 100, as illustrated in FIG. 13A.

Briefly, in operation, the handle assembly 400 assists a user indeploying the closure element 100 within an opening in a body lumen. Forexample, after the closure element 100 is positioned appropriatelywithin the opening in the body lumen, as discussed above, the user mayturn the handle element 402, which in turn assists to deploy the closureelement 100. Specifically, the handle element 402 may be coupled to theactuator 22 such that as the handle element 402 is rotated, the actuatorapplies a force upon the closure element 100 that causes the closureelement 100 to change from a delivery configuration to a deployedconfiguration, as discussed above.

The handle assembly 400, shown in FIG. 13A, may vary from one embodimentto the next. For example, the handle element 402 is one example aspectof the handle assembly 400 that may vary. FIG. 13B shows a bottom viewof the handle element 402. The bottom view of the handle element 402illustrates the grip portion 410, the extended portion 412, and theprojections 414 that extend from or project out from the extendedportion 412. Moreover, FIG. 13B illustrates the port 416 through whichthe actuator 22 may extend.

The geometric configuration is one way in which the handle element 402may vary. As illustrated in FIG. 13B, the geometric configuration of thehandle element 402 may have a substantially circular cross-sectionalconfiguration. However, in other example embodiments, thecross-sectional configuration of the handle element including theextended portion 412 and the grip portion 410 may have various othergeometric configurations such as square, rectangle, triangle or anyother configuration or combination of configurations.

Moreover, and as shown in FIGS. 13A and 13D, the handle element 402 mayinclude a set screw 428. The set screw 428 may be positioned in the gripportion 410 such that a set screw may be used to secure the position ofthe actuator 22. FIG. 13D illustrates how the set screw 428 may bepositioned such to enter from the side of the grip portion 410 and intothe port 416, and thus, secure the actuator 22.

Another way in which the handle element 402 may vary is thecharacteristics of the projections 414. As shown in FIG. 13D, theprojections 414 may be made from a different piece of material than theextended portion 412. In alternate embodiments, the projections 414 maybe manufactured out of the same piece of material as the extendedportion 412.

Not only can the manufacture method vary with respect to the projections414, but the location of the projections 414 on the extended portion 412may vary from one embodiment to the next. As illustrated in FIGS. 13Aand 13D, the projections 414 may be located on the distal end 408 of thehandle element 402. However, in alternative embodiments, the projections414 may be located at various other locations or almost any location onthe extended portion 412.

Another aspect of the handle element 402 that may vary from oneembodiment to the next is the grip portion 410. The grip portion 410 maybe sized such that a human finger or a human hand would be able toeasily turn and twist the grip portion 410. In order to help with thetwisting of the handle element 402, the grip portion 410 may include afriction provider such as a piece of rubber or a pattern within thesidewall of the grip portion to aid in helping a human hand grip thegrip portion 410 and turn the handle element 402.

In addition to various geometric characteristics, the handle element 402may vary in material composition. For example, in one example embodimentthe handle element 402 may be made from a metal such as stainless steel.Other materials may be used to make the handle element 402 such asplastics, ceramics or any other material that would have structurallysuitable properties.

Just as the handle element 402 may vary from one embodiment to the next,so too may the hub member 404. For example, the cross-sectionalconfiguration of the hub member 404 may vary from one embodiment to thenext. The hub member, as illustrated in FIG. 13A, has a substantiallycircular cross-sectional geometric configuration. Alternatively, inother example embodiments, the hub member 404 may have a cross-sectionalgeometric configuration that is square, rectangular, hexagonal, or anyother configuration or combination of configurations.

Notwithstanding the cross-sectional configuration of the hub member 404,the way in which the channel 424 is located throughout the hub member404 may vary. For example, and as illustrated in FIG. 13A, the channel424 is configured such that the handle element 402 is allowed to rotateone full turn within the hub member 404. Alternatively, the channel 424may be configured to allow more or less rotation of the handle element402. In one example embodiment, the channel 424 may only allow for ahalf turn of the handle element 402. Alternatively, in other embodimentsof the invention, the channel 424 may allow for multiple rotations ofthe handle element 402.

In addition to the number of rotations in which the channel 424 allowsthe handle element 402 to make, the channel 424 may also be configuredwith various pathways. For example, and as illustrated in FIG. 13A, thepathway of the channel 424 is relatively smooth from the bottom portionof the channel 424 around to the top portion of the channel 424.However, in alternative embodiments, the channel 424 may have stepsections such that the projections 414 on the handle element 402 movewithin the channel at various steps from one depth to the next. Inanother example embodiment, the channel 424 may direct the handleelement 402 to move with a combination of relatively smooth movementsand stepped movements.

The operation of the handle assembly 400 will be discussed in furtherdetail with reference to FIGS. 13C through 13G. The handle element 402is inserted within a receiving area 426 located within the hub member404, as illustrated in FIG. 13D. The projections 414 located on theextended portion 412 of the handle element 402 interact with the channel424 on the hub member 404 such that as the handle element 402 is turned,the position of the handle element relative to the hub member 404changes.

For example, and as illustrated in FIG. 13C, the handle element 402 islocated towards the distal end of the hub member 404. When the handleelement 402 is rotated, the projections 414 follow the channels 424 suchthat the handle element 402 moves in the proximal direction with respectto the hub member 404, as illustrated in more detail in FIGS. 13E and13F. Moreover, if the actuator 22 is secured to the handle element 402by way of the set screw 428, then as the handle element 402 moves in theproximal direction with respect to hub member 404, the handle element402 also pulls the actuator 22 in the proximal direction. Thus, as thehandle element 402 is rotated, the actuator 22 is pulled in a proximaldirection and the closure element 100 may be deployed, as previouslydescribed with relation to FIGS. 3 through 6.

In one specific embodiment, the closure element 100 with the handleassembly 400 cooperates with an introducer sheath 500, as illustrated inFIG. 13G. The introducer sheath 500 may include an introducer elongatemember 502. The elongate member 12 and the closure element 100 arepassed through the introducer sheath 500 and extend through theintroducer elongate member 502 such that the closure element 100protrudes from the distal end of the introducer elongate member 502. Inone example embodiment, the closure element 100 has the distal slitsprotruding from the introducer elongate member 502.

In operation, the introducer sheath 500 may already be positioned suchthat the introducer elongate member 502 is located at least partiallywithin the body lumen or extended through an opening in a body lumenwall. The closure element 100, along with the elongate member 12, maythen be introduced into the introducer sheath 500 and positioned withinthe opening in the body lumen. With the closure device located withinthe introducer sheath 500, the handle element 402 may be rotated suchthat the actuator 22 is pulled in the proximal direction and the loweror distal region of the closure element 100 changes from a deliveryconfiguration to a deployed configuration, as shown in FIG. 13E.

After the first portion of the closure element has been deployed, theintroducer sheath 500 and the introducer elongate member 502 may bemoved in the proximal direction such as to uncover the proximal slits110. At this point, the handle element 402 may be again twisted orrotated such that the actuator 22 is moved or pulled in the proximaldirection, thus deploying the upper portion of the closure element 100,as shown in FIG. 13F.

The amount of rotation that may be needed to deploy the closure element100 or change the closure element 100 from a delivery configuration to adeployed configuration may vary. In one example embodiment, the handleelement 402 may be turned one half of a turn to deploy the first portionof the closure element 100 and then turned another half of a turn todeploy the second portion of the closure element 100. However, in otherexample embodiments it is understood that larger or smaller rotation maybe used to deploy the closure element 100.

Once the closure element 100 is deployed and in place within the bodylumen wall, the remainder of the closure device and the introducersheath can be removed in a similar manner as described with respect toFIGS. 3-6.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope. It shall be furtherunderstood that although the present invention has been described inrelation to vessel closure, it is contemplated that the closurecomponent of the present invention may be utilized to close otheropenings in the body such as PFO openings, or openings formed in organssuch as the stomach for certain surgical procedures.

1.-25. (canceled)
 26. A method of closing an opening in a blood vessel,the method comprising: positioning a closure element through the openingin the blood vessel and within a lumen of a tubular member, the tubularmember applying a radial compressive force to the closure element;following expanding of a distal portion of the closure element from apre-deployed configuration to a deployed configuration, engaging aninside portion of the blood vessel with the distal portion of theclosure element; and following engaging the inside portion of the bloodvessel with the closure element through proximal movement of the closureelement and deployment of a proximal portion of the closure element froma pre-deployed configuration to a deployed configuration, engaging aproximal portion of the closure element with an outside portion of theblood vessel.
 27. The method of claim 26, further comprising releasingthe closure element from an elongate member releasably connected to theclosure element.
 28. The method of claim 27, wherein releasing theclosure element comprises cutting the elongate member.
 29. The method ofclaim 27, wherein releasing the closure element comprises applying aforce to a weakened portion to break the elongate member.
 30. The methodof claim 27, wherein the closure element is made from bioabsorbable,bioerodible, biodegradable, and/or bioresorbable material.
 31. Themethod of claim 26, further comprising positioning the closure elementat a predetermined depth within the tubular member with at least aportion of the closure element extending beyond a distal end of thetubular member.
 32. The method of claim 26, wherein the closure elementhas a curved distal end in cross section.
 33. A method of closing anopening in tissue of a blood vessel, the method comprising: positioninga closure element within a lumen of a tubular member and within theblood vessel, the tubular member having a bias and applying a radialcompressive force to the closure element, a portion of the closureelement extending distally beyond a distal end of the tubular member ina pre-deployed configuration of a distal portion of the closure element;following expanding of the distal portion of the closure element fromthe pre-deployed configuration to a deployed configuration, withdrawingthe closure element proximally to engage an inside portion of the bloodvessel with the distal portion of the closure device; followingcontacting the inside portion of the blood vessel with the closureelement, deploying a proximal portion of the closure element from apre-deployed configuration to a deployed configuration; engaging theproximal portion of the closure element with an outside portion of theblood vessel; and releasing the closure element from an elongate memberreleasably connected to the closure element.
 34. The method of claim 33,wherein expanding of the distal portion of the closure element comprisesproximally withdrawing the elongate member to at least partially movethe portion of the closure element which is distal an intermediateportion of the closure element towards the intermediate portion.
 35. Themethod of claim 33, wherein deploying the proximal portion of theclosure element comprises proximally withdrawing the elongate member toat least partially move the portion of the closure element which isdistal the intermediate portion of the closure element towards aproximal portion of the closure element.
 36. The method of claim 35,further comprising locking the proximal portion in the deployedconfiguration.
 37. The method of claim 33, wherein engaging the proximalportion of the closure element with the outside portion of the bloodvessel applies a clamping force upon the blood vessel.
 38. The method ofclaim 33, further comprising positioning a hemostatic agent proximal theproximal portion.
 39. The method of claim 33, further comprisingdeploying a hemostatic material on or adjacent to the opening in thetissue.
 40. A method of closing an opening in a blood vessel, the methodcomprising: positioning a closure element within the blood vessel and atleast partially extending from a distal end of a tubular member, thetubular member having a bias and applying a radial compressive force tothe closure element; reconfiguring a distal, tissue engaging portion ofthe closure element from a pre-deployed configuration to a deployedconfiguration; withdrawing the closure element proximally to engage aninside portion of the blood vessel with the distal, tissue engagingportion, a portion of the distal; following contacting the insideportion of the blood vessel with the closure element, deploying aproximal portion of the closure element from a pre-deployedconfiguration to a deployed configuration; engaging the proximal portionof the closure element with an outside portion of the blood vessel; andreleasing the closure element from an elongate member releasablyconnected to the closure element.
 41. The method of claim 40, furthercomprising locking a position of the distal portion.
 42. The method ofclaim 40, further comprising locking a position of the proximal portion.43. The method of claim 40, wherein a portion of the closure element towhich the elongate member extends through is positioned proximal theproximal portion engaging with the outside portion of the blood vessel.44. The method of claim 40, wherein the elongate member extends througha portion of the closure element.
 45. The method of claim 40, furthercomprising compressively restraining the proximal portion of the closuredevice within the tubular member.